|By PR Newswire||
|February 24, 2013 01:18 PM EST||
EAST HANOVER, N.J., Feb. 24, 2013 /PRNewswire/ -- Late-breaking results from ASTERIA II, a Phase III placebo-controlled study, showed positive results in patients with moderate to severe chronic idiopathic urticaria (CIU), referred to as chronic spontaneous urticaria (CSU) outside the United States, who remained symptomatic despite treatment with approved antihistamine doses. The data were published today in the New England Journal of Medicine and will be presented tomorrow at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in San Antonio, Texas. Omalizumab is not indicated for CIU.
The primary endpoint was measured using a 21-point scale known as a weekly Itch Severity Score (ISS). The study met its primary endpoint, showing that omalizumab given at doses of 150 mg and 300 mg every four weeks led to significant improvement from baseline at Week 12 in the mean weekly ISS from baseline (approximately 14 in all treatment groups) by 8.1 (p=0.001) and 9.8 (p<0.001), respectively, compared to a 5.1 improvement in patients on placebo. The omalizumab 75 mg dose group did not demonstrate statistical significance compared to placebo for the primary endpoint. All eight pre-specified secondary endpoints in the ASTERIA II trial were met for the 150 mg and 300 mg doses, except for the 150 mg dose that did not show a significant difference from placebo in the proportion of angioedema-free days from Week 4 to Week 12 of therapy.
CIU is a distressing skin condition characterized by red, swollen, itchy and sometimes painful hives on the skin, spontaneously presenting and reoccurring for more than six weeks. At any given time, the prevalence of CIU is 0.5% to 1% worldwide. While antihistamines are used first to treat CIU, more than 50% of patients are unable to achieve symptom relief with approved doses.
"These results indicate that omalizumab could potentially be an important addition in the treatment of chronic idiopathic urticaria, a disease that can have a significant impact on patients and can be challenging to manage," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "We are committed to helping patients with this disease and look forward to receiving further results from ongoing longer-term clinical trials."
ASTERIA II is the first Phase III data to be presented from a clinical trial program in CIU, which also includes two additional studies investigating the efficacy and safety profile of omalizumab over 24 weeks treatment duration. Novartis regulatory submissions are on track for 2013.
"These results are encouraging news for appropriate patients whose CIU is unresponsive to antihistamines," said study co-lead investigator, Thomas Casale, MD, Chief of Allergy & Immunology at Creighton University Medical Center and Professor of Medicine and Medical Microbiology at Creighton University, Omaha, NE. "New and effective therapeutic strategies for CIU are necessary as treatment options are limited for these patients."
ASTERIA II was a global, multi-center, randomized, double-blind study that evaluated the efficacy and safety profile of omalizumab compared to placebo and involved 323 patients aged between 12 and 75 with a diagnosis of moderate to severe CIU for at least six months. Patients were required to have the presence of itch and hives for at least eight consecutive weeks at any time prior to enrollment despite use of approved doses of H1 antihistamine treatment. Patients were randomized to omalizumab 75 mg, 150 mg or 300 mg or placebo, given subcutaneously every four weeks, for a total of three doses within a 12-week treatment period, with a 16-week follow-up period. Patients continued to receive stable doses of their pre-randomization H1 antihistamine. For the primary endpoint, the omalizumab 75 mg dose group did not demonstrate statistical significance compared to placebo. However, omalizumab 150 mg and 300 mg dose groups met the pre-specified primary endpoint and all eight pre-specified secondary endpoints in the ASTERIA II trial, except for the 150 mg dose that did not show a significant difference from placebo in the proportion of angioedema-free days from Week 4 to Week 12 of therapy. Patient response, as measured by the median time to Minimally Important Difference (MID) in itch severity score, a secondary endpoint, occurred at Week 1 (300 mg dose) and Week 2 (150 mg dose), compared to Week 4 in the placebo group.
The incidence and severity of adverse events (AEs) was similar across treatment groups. The most frequently reported treatment-emergent adverse events in patients taking omalizumab (>10% in any omalizumab treatment arm) in the study (including treatment period and follow-up period) were nasopharyngitis (nasal and throat infection or common cold), idiopathic urticaria (hives and itching, trigger unknown) and headache. Five (6.3%) patients experienced serious adverse events (SAEs) in the omalizumab 300 mg dose group, compared to two (2.5%) in the placebo group. In the 150 mg and 75 mg dose groups, one patient experienced SAEs in each group (1.1% and 1.3%, respectively). No deaths were reported during this study.
Omalizumab is not indicated for CIU.
Omalizumab is a biologic therapy unique in targeting immunoglobulin E (IgE). Research is ongoing to understand the mechanism of action of omalizumab in CIU and to investigate its potential impact on the drivers of CIU. Omalizumab is approved for the treatment of moderate to severe allergic asthma under the brand-name Xolair® in more than 90 countries, including the US since 2003 and the EU since 2005. In the US, Xolair is indicated for appropriate people who are 12 years of age and older who have moderate to severe persistent allergic asthma caused by year-round allergens in the air and are uncontrolled on inhaled corticosteroids. Xolair helps reduce the number of asthma attacks in people with allergic asthma who still have asthma symptoms even though they are taking inhaled steroids. Xolair should not be used to treat other allergic conditions. Xolair is not a rescue medicine and should not be used to treat sudden asthma attacks. Xolair should not be used in children under 12 years of age.
Omalizumab is being jointly developed by Novartis and Genentech. In the US, Xolair® (omalizumab) for subcutaneous use in appropriate allergic asthma patients is co-promoted by Novartis Pharmaceuticals Corporation and Genentech.
About Xolair® (omalizumab) for subcutaneous use
Important Safety Information: Appropriate Moderate-Severe Allergic Asthma Patients
Xolair should always be injected in a doctor's office. Patients should read the Medication Guide before starting Xolair treatment and before each and every treatment.
A severe allergic reaction called anaphylaxis has happened in some patients after they received Xolair. Anaphylaxis is a life-threatening condition and can lead to death. Patients must seek emergency medical treatment right away if symptoms occur.
Signs and symptoms of anaphylaxis include:
- wheezing, shortness of breath, cough, chest tightness, or trouble breathing
- low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom"
- flushing, itching, hives, or feeling warm
- swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
Anaphylaxis from Xolair can happen:
- right after receiving a Xolair injection or hours later
- after any Xolair injection. Anaphylaxis has occurred after the first Xolair injection or after many Xolair injections.
A patient's healthcare provider should watch the patient for some time in the office for signs or symptoms of anaphylaxis after injecting Xolair. If patients have signs or symptoms of anaphylaxis, they must tell their healthcare provider right away.
Patients must not receive Xolair if they have ever had an allergic reaction to a Xolair injection. Patients should not use Xolair if they are allergic to any of its ingredients.
In clinical studies, a variety of cancer types, including breast, skin, prostate, and parotid (a type of salivary gland), were reported in more patients who received Xolair than in patients who did not receive Xolair.
Xolair is not a rescue medicine and should not be used to treat sudden asthma attacks.
Xolair is not a substitute for the medicines patients are already taking. Patients must not change or stop taking any of their other asthma medicines unless their doctor tells them to do so.
Some patients on Xolair may have an abnormal increase in eosinophils (a type of white blood cell) in the blood or tissues, sometimes causing an inflammation of blood vessels which can lead to rash, worsening of respiratory symptoms, heart trouble, and/or nerve pain and weakness.
Joint inflammation or pain, rash, fever, and swollen lymph nodes have been seen in some patients taking Xolair after the first or subsequent injections. Patients should talk to their doctor if they have experienced any of these signs and symptoms.
In allergic asthma studies, the most commonly seen side effects occurring more frequently in patients receiving Xolair than in patients who received placebo (an injection with no active medicine) were joint pain, pain (general), leg pain, tiredness (fatigue), dizziness, fracture, arm pain, itching, inflammation of the skin, and earache.
In allergic asthma studies, the most common side effects in patients, who either needed to stop Xolair or needed medical attention, were injection site reaction, viral infections, upper respiratory tract infection, sinusitis, headache, and sore throat. These side effects were seen at similar rates in Xolair-treated patients as in patients that did not receive Xolair.
There are other possible side effects with Xolair. Patients should talk to their doctor for more information and if they have any questions about their treatment.
Xolair has not been studied in pregnant women. Pregnant women exposed to Xolair are encouraged to enroll in the Xolair Pregnancy Exposure Registry. Patients can get more information by calling 1-866-4XOLAIR (1-866-496-5247) or by speaking with their doctor.
For the full Prescribing Information, including Boxed WARNINGS and Medication Guide for additional important safety information please log onto http://www.pharma.us.novartis.com/cs/www.pharma.us.novartis.com/product/pi/pdf/Xolair.pdf or contact Christine Cascio at 862-778-8026.
The foregoing release contains forward-looking statements that can be identified by terminology such as "to be," "will be," "to investigate," "potentially," "could," "committed," "look forward to," "on track," "potential," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for omalizumab or regarding potential future revenues from omalizumab. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with omalizumab to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that omalizumab will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that omalizumab will achieve any particular levels of revenue in the future. In particular, management's expectations regarding omalizumab could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; government, industry and general public pricing pressures; competition in general; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative prescription drugs used to treat a number of diseases and conditions, including cardiovascular, dermatological, central nervous system, bone disease, cancer, organ transplantation, psychiatry, infectious disease and respiratory. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
Novartis Media Relations
+1 212 830 2465 (direct)
+1 862 579 8456 (mobile)
Novartis Pharmaceuticals Corporation
+1 862 778 8026 (direct)
+1 862 926 7992 (mobile)
e-mail: [email protected]
SOURCE Novartis Pharmaceuticals Corporation
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data shows "less than 10 percent of IoT developers are making enough to support a reasonably sized team....
Nov. 28, 2015 01:00 PM EST Reads: 473
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound cha...
Nov. 28, 2015 12:00 PM EST Reads: 548
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
Nov. 28, 2015 12:00 PM EST Reads: 333
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, rich desktop and tuned mobile experiences can now be created with a single codebase – without compromising functionality, performance or usability. In his session at DevOps Summit, Charles Kendrick, CTO and Chief Architect at Isomorphic Software, demonstrated examples of com...
Nov. 28, 2015 11:45 AM EST Reads: 400
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningful and actionable insights. In his session at @ThingsExpo, Paul Turner, Chief Marketing Officer at...
Nov. 28, 2015 11:15 AM EST Reads: 412
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Nov. 28, 2015 11:00 AM EST Reads: 512
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Nov. 28, 2015 10:30 AM EST Reads: 309
We all know that data growth is exploding and storage budgets are shrinking. Instead of showing you charts on about how much data there is, in his General Session at 17th Cloud Expo, Scott Cleland, Senior Director of Product Marketing at HGST, showed how to capture all of your data in one place. After you have your data under control, you can then analyze it in one place, saving time and resources.
Nov. 28, 2015 10:00 AM EST Reads: 191
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, exploreed the current state of IoT connectivity and review key trends and technology requirements that will drive the Internet of Things from hype to reality.
Nov. 28, 2015 08:45 AM EST Reads: 434
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessions, I wanted to share some of my observations on emerging trends. As cyber security serves as a fou...
Nov. 28, 2015 08:45 AM EST Reads: 331
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now all corporate assets – people, objects, and spaces – can share information about themselves and thei...
Nov. 28, 2015 06:00 AM EST Reads: 246
Continuous processes around the development and deployment of applications are both impacted by -- and a benefit to -- the Internet of Things trend. To help better understand the relationship between DevOps and a plethora of new end-devices and data please welcome Gary Gruver, consultant, author and a former IT executive who has led many large-scale IT transformation projects, and John Jeremiah, Technology Evangelist at Hewlett Packard Enterprise (HPE), on Twitter at @j_jeremiah. The discussion is moderated by me, Dana Gardner, Principal Analyst at Interarbor Solutions.
Nov. 28, 2015 05:30 AM EST Reads: 731
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Nov. 28, 2015 05:00 AM EST Reads: 362
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true change and transformation possible.
Nov. 28, 2015 04:00 AM EST Reads: 541
The Internet of Things is clearly many things: data collection and analytics, wearables, Smart Grids and Smart Cities, the Industrial Internet, and more. Cool platforms like Arduino, Raspberry Pi, Intel's Galileo and Edison, and a diverse world of sensors are making the IoT a great toy box for developers in all these areas. In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists discussed what things are the most important, which will have the most profound effect on the world, and what should we expect to see over the next couple of years.
Nov. 28, 2015 03:30 AM EST Reads: 475
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem" in this scenario: microservice A (releases daily) depends on a couple of additions to backend B (re...
Nov. 28, 2015 03:00 AM EST Reads: 451
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Yet a closer inspection at the data reveals less than half of these cloud projects involve production...
Nov. 28, 2015 03:00 AM EST Reads: 482
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Day 2 Keynote at 17th Cloud Expo, Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, wil...
Nov. 28, 2015 02:00 AM EST Reads: 580
PubNub has announced the release of BLOCKS, a set of customizable microservices that give developers a simple way to add code and deploy features for realtime apps.PubNub BLOCKS executes business logic directly on the data streaming through PubNub’s network without splitting it off to an intermediary server controlled by the customer. This revolutionary approach streamlines app development, reduces endpoint-to-endpoint latency, and allows apps to better leverage the enormous scalability of PubNub’s Data Stream Network.
Nov. 28, 2015 02:00 AM EST Reads: 329
Container technology is shaping the future of DevOps and it’s also changing the way organizations think about application development. With the rise of mobile applications in the enterprise, businesses are abandoning year-long development cycles and embracing technologies that enable rapid development and continuous deployment of apps. In his session at DevOps Summit, Kurt Collins, Developer Evangelist at Built.io, examined how Docker has evolved into a highly effective tool for application delivery by allowing increasingly popular Mobile Backend-as-a-Service (mBaaS) platforms to quickly crea...
Nov. 28, 2015 02:00 AM EST Reads: 361